BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1802724 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08723
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    January 12, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CORRECTED THE PATIENT EVENT DESCRIPTION TO DETAIL THAT HIS EVENT OCCURRED ON THE (B)(4) .

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVERSE EVENT RELATED TO THE DEVICE RIGHT ATRIAL LEAD RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION. HIGH/ELEVATED PACING THRESHOLD WAS OBSERVED. THE POLARITY ON THE ATRIAL LEAD WAS CHANGED FROM BIPOLAR TO UNIPOLAR AND THE ATRIAL AMPLITUDE WAS INCREASED. LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOW-UP DETERMINED THAT THE COMPLAINT WAS ACTUALLY ON A COMPETITOR LEAD, AND THAT THE MEDTRONIC LEAD IN QUESTION WAS ITS REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVERSE EVENT RELATED TO THE DEVICE RIGHT ATRIAL LEAD RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION. HIGH/ELEVATED PACING THRESHOLD WAS OBSERVED. THE POLARITY ON THE ATRIAL LEAD WAS CHANGED FROM BIPOLAR TO UNIPOLAR AND THE ATRIAL AMPLITUDE WAS INCREASED. LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADVERSE EVENT RELATED TO THE DEVICE RIGHT ATRIAL LEAD RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT TO BODY STRUCTURE OR BODY FUNCTION. HIGH/ELEVATED PACING THRESHOLD WAS OBSERVED. THE POLARITY ON THE ATRIAL LEAD WAS CHANGED FROM BIPOLAR TO UNIPOLAR AND THE ATRIAL AMPLITUDE WAS INCREASED. LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FOLLOW UP INFORMATION OBTAINED REVEALED THAT THIS EVENT (WHICH OCCURRED (B)(6) 2009) OCCURRED ON THE (B)(4) THAT WAS IMPLANTED (B)(6) 2009. THE MEDTRONIC (B)(4) LEAD WAS THE REPLACEMENT FOR THE (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R